JPWO2021123104A5 - - Google Patents

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JPWO2021123104A5
JPWO2021123104A5 JP2022537135A JP2022537135A JPWO2021123104A5 JP WO2021123104 A5 JPWO2021123104 A5 JP WO2021123104A5 JP 2022537135 A JP2022537135 A JP 2022537135A JP 2022537135 A JP2022537135 A JP 2022537135A JP WO2021123104 A5 JPWO2021123104 A5 JP WO2021123104A5
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gene
rhvt
expression cassette
aiv
poultry
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JP2022537135A
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JP2023506919A (en
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Priority claimed from PCT/EP2020/086940 external-priority patent/WO2021123104A1/en
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Claims (18)

ｒＨＶＴのゲノムのユニーク短（Ｕｓ）領域に挿入された第１および第２の発現カセットから、感染性ファブリキウス嚢病ウイルス（ＩＢＤＶ）ウイルスタンパク質２（ＶＰ２）遺伝子と、ニューカッスル病ウイルス（ＮＤＶ）融合（Ｆ）タンパク質遺伝子とを発現する、組換え七面鳥ヘルペスウイルス（ｒＨＶＴ）であって、
前記ｒＨＶＴは、前記ｒＨＶＴのゲノムのユニーク長（ＵＬ）領域のＵＬ４０遺伝子とＵＬ４１遺伝子との間、またはＵＬ４４遺伝子とＵＬ４５遺伝子との間のいずれかに挿入された第３の発現カセットから鳥インフルエンザウイルス（ＡＩＶ）ヘムアグルチニン（ＨＡ）遺伝子も発現することを特徴とする、組換え七面鳥ヘルペスウイルス（ｒＨＶＴ）。 The infectious bursal disease virus (IBDV) viral protein 2 (VP2) gene and the Newcastle disease virus (NDV) fusion ( F) a recombinant turkey herpesvirus (rHVT) expressing a protein gene,
The rHVT is derived from an avian influenza virus from a third expression cassette inserted either between the UL40 and UL41 genes or between the UL44 and UL45 genes in the unique length (UL) region of the genome of the rHVT. (AIV) A recombinant turkey herpesvirus (rHVT) characterized in that it also expresses the hemagglutinin (HA) gene. ＩＢＤＶ ＶＰ２遺伝子が、５’から３’方向に、
ａ．マウスサイトメガロウイルス前初期１遺伝子（ｍＣＭＶ－ＩＥ１）プロモーター、
ｂ．ＩＢＤＶ ＶＰ２遺伝子、および
ｃ．転写ターミネーター、
を、この順序で含む第１の発現カセットから発現され、
それによって、前記発現カセットのプロモーターおよびターミネーターが、前記ＶＰ２遺伝子に作動可能に連結されていることを特徴とする、請求項１に記載のｒＨＶＴ。 The IBDV VP2 gene is in the 5' to 3' direction,
a. Mouse cytomegalovirus immediate early 1 gene (mCMV-IE1) promoter,
b. IBDV VP2 gene, and c. transcription terminator,
expressed from a first expression cassette comprising in this order:
rHVT according to claim 1, characterized in that the promoter and terminator of the expression cassette are thereby operably linked to the VP2 gene. ＮＤＶ Ｆ遺伝子が、５’から３’方向に、
ａ．ヒトサイトメガロウイルス前初期１遺伝子（ｈＣＭＶ－ＩＥ１）プロモーター、
ｂ．ＮＤＶ Ｆタンパク質遺伝子、および
ｃ．転写ターミネーター、
を、この順序で含む第２の発現カセットから発現され、
それによって、前記発現カセットのプロモーターおよびターミネーターが、前記Ｆ遺伝子に作動可能に連結されていることを特徴とする、請求項１または２に記載のｒＨＶＴ。 The NDV F gene is in the 5' to 3' direction,
a. human cytomegalovirus immediate early 1 gene (hCMV-IE1) promoter,
b. an NDV F protein gene, and c. transcription terminator,
expressed from a second expression cassette comprising in this order:
rHVT according to claim 1 or 2, characterized in that the promoter and terminator of the expression cassette are thereby operably linked to the F gene. 前記第１および前記第２の発現カセットが、前記ｒＨＶＴのゲノムのＵｓ領域の同じ遺伝子座または異なる遺伝子座に挿入されることを特徴とする、請求項１～３のいずれか一項に記載のｒＨＶＴ。 4. The method according to claim 1, wherein the first and second expression cassettes are inserted into the same or different loci of the Us region of the genome of the rHVT. rHVT. 前記第１および前記第２の発現カセットの両方が、前記Ｕｓ２遺伝子に挿入されるか、または両方が前記Ｕｓ１０遺伝子に挿入されるか、または一方が前記Ｕｓ２遺伝子に挿入され、他方が、前記Ｕｓ１０遺伝子に挿入されることを特徴とする、請求項１～４に記載のｒＨＶＴ。 Both the first and second expression cassettes are inserted into the Us2 gene, or both are inserted into the Us10 gene, or one is inserted into the Us2 gene and the other is inserted into the Us10 gene. rHVT according to claims 1 to 4, characterized in that it is inserted into a gene. 前記第１および前記第２の発現カセットが、単一発現カセット内に組み合わされることを特徴とする、請求項１～５に記載のｒＨＶＴ。 rHVT according to claims 1 to 5, characterized in that the first and second expression cassettes are combined into a single expression cassette. 前記組み合わせた単一発現カセットが、前記Ｕｓ２遺伝子に挿入されることを特徴とする、請求項６に記載のｒＨＶＴ。 rHVT according to claim 6, characterized in that the combined single expression cassette is inserted into the Us2 gene. 前記ＡＩＶ ＨＡ遺伝子が、５’から３’方向に、
ａ．哺乳動物ヘルペスウイルス由来の糖タンパク質Ｂ（ｇＢ）遺伝子プロモーター、
ｂ．ＡＩＶ ＨＡタンパク質遺伝子、および
ｃ．転写ターミネーター、
を、この順序で含む第３の発現カセットから発現され、
それによって、前記発現カセットのプロモーターおよびターミネーターが、前記ＨＡ遺伝子に作動可能に連結されていることを特徴とする、請求項１～７のいずれか一項に記載のｒＨＶＴ。 The AIV HA gene is in the 5' to 3' direction,
a. a glycoprotein B (gB) gene promoter derived from a mammalian herpesvirus;
b. an AIV HA protein gene, and c. transcription terminator,
expressed from a third expression cassette containing in this order:
rHVT according to any one of claims 1 to 7, characterized in that the promoter and terminator of the expression cassette are thereby operably linked to the HA gene. 前記ＡＩＶ ＨＡタンパク質遺伝子が、Ｈ５、Ｈ７およびＨ９から選択される血清型のＨＡタンパク質をコードすることを特徴とする、請求項１～８のいずれか一項に記載のｒＨＶＴ。 rHVT according to any one of claims 1 to 8, characterized in that the AIV HA protein gene encodes a HA protein of a serotype selected from H5, H7 and H9. 請求項１～９のいずれか一項に記載のｒＨＶＴを含む宿主細胞。 A host cell comprising rHVT according to any one of claims 1 to 9. 家禽用ワクチンに使用するための、請求項１～９のいずれか一項に記載のｒＨＶＴおよび／または請求項１０に記載の宿主細胞。 rHVT according to any one of claims 1 to 9 and/or a host cell according to claim 10 for use in poultry vaccines. 請求項１～９のいずれか一項に記載のｒＨＶＴおよび／または請求項１０に記載の宿主細胞と、薬学的に許容される担体とを含む家禽用ワクチン。 A poultry vaccine comprising the rHVT according to any one of claims 1 to 9 and/or the host cell according to claim 10 and a pharmaceutically acceptable carrier. 少なくとも１つの追加の免疫活性成分を含む、請求項１２に記載のワクチン。 13. The vaccine according to claim 12, comprising at least one additional immunoactive component. 請求項１２または１３に記載の家禽用ワクチンの調製方法であって、
該方法は、
ａ．請求項１～９のいずれか一項に記載のｒＨＶＴを、インビトロで宿主細胞に感染させる工程、
ｂ．前記感染した宿主細胞を回収する工程、および
ｃ．前記回収した感染宿主細胞を、薬学的に許容される担体と混合する工程、
を含む方法。 A method for preparing a poultry vaccine according to claim 12 or 13,
The method includes:
a. Infecting a host cell in vitro with rHVT according to any one of claims 1 to 9;
b. collecting said infected host cells; and c. mixing the recovered infected host cells with a pharmaceutically acceptable carrier;
method including. 家禽用ワクチンの製造のための、請求項１～９のいずれか一項に記載のｒＨＶＴ、請求項１０に記載の宿主細胞、またはそれらの任意の組み合わせの使用。 Use of rHVT according to any one of claims 1 to 9, a host cell according to claim 10, or any combination thereof for the production of poultry vaccines. ＭＤＶ、ＩＢＤＶ、ＮＤＶおよび／もしくはＡＩＶによる感染、またはそれらに関連する疾患の徴候を予防または軽減するための、請求項１２または１３に記載のワクチンの使用。 14. Use of a vaccine according to claim 12 or 13 for preventing or reducing infection by MDV, IBDV, NDV and/or AIV, or symptoms of diseases associated therewith. ＭＤＶ、ＩＢＤＶ、ＮＤＶおよび／もしくはＡＩＶによる感染またはそれらに関連する疾患の徴候を予防または軽減する方法であって、請求項１２または１３のいずれか一項に記載のワクチンの家禽への投与を含む方法。 14. A method of preventing or reducing symptoms of infection by or diseases associated with MDV, IBDV, NDV and/or AIV, comprising administering to poultry a vaccine according to any one of claims 12 or 13. Method. ＭＤＶ、ＩＢＤＶ、ＮＤＶおよび／もしくはＡＩＶによる感染またはそれらに関連する疾患徴候を予防または軽減するための家禽へのワクチン接種方法であって、前記家禽に請求項１２または１３に記載のワクチンを接種する工程を含む、方法。 A method of vaccinating poultry to prevent or reduce infection by MDV, IBDV, NDV and/or AIV or disease symptoms associated therewith, comprising vaccinating said poultry with the vaccine according to claim 12 or 13. A method, including a process.
JP2022537135A 2019-12-20 2020-12-18 Multivalent HVT vector vaccine Pending JP2023506919A (en)

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EP19218804 2019-12-20
EP19218804.3 2019-12-20
PCT/EP2020/086940 WO2021123104A1 (en) 2019-12-20 2020-12-18 Multivalent hvt vector vaccine

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EP (1) EP4076516A1 (en)
JP (1) JP2023506919A (en)
CN (1) CN114828882A (en)
BR (1) BR112022010825A2 (en)
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WO2023213946A1 (en) * 2022-05-05 2023-11-09 Intervet International B.V. New multivalent hvt vector vaccine

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